• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE Back to Search Results
Model Number VPR-GW-FLEX14
Device Problem Entrapment of Device (1212)
Patient Problems Perforation of Vessels (2135); Vascular Dissection (3160)
Event Date 02/01/2021
Event Type  Injury  
Manufacturer Narrative
Csi is attempting to reach out to the physician involved in this case for additional information. As of now, the results of the investigation are inconclusive since the reported device was not returned for analysis. Based on the information received, the cause of the reported event could not be conclusively determined. If additional relevant information is received from the physician, a supplemental report will be submitted. The device history record for the reported oad could not be reviewed, as the lot number was not provided. If the lot number is provided, a dhr review will be performed. (b)(4).
 
Event Description
The peripheral orbital atherectomy device (oad) became stuck in the tibial artery during use. A dissection and perforation occurred. Angioplasty was performed to resolve the issue.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
Type of DevicePERIPHERAL ATHERECTOMY DEVICE
Manufacturer (Section D)
CARDIOVASCULAR SYSTEMS, INC.
1225 old hwy 8 nw
st. paul MN 55112
Manufacturer (Section G)
CARDIOVASCULAR SYSTEMS, INC.
1225 old hwy 8 nw
st. paul MN 55112
Manufacturer Contact
morgan hill
1225 old hwy 8 nw
st. paul, MN 55112
MDR Report Key11421455
MDR Text Key234925826
Report Number3004742232-2021-00070
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190634
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2021
Device Model NumberVPR-GW-FLEX14
Device Catalogue Number7-10041-03
Device Lot Number306961
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/20/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-